Serial Number Decommissioning Pilot Report

November 7, 2024

Categories: News Release

The Drug Supply Chain Security Act (DSCSA) requires the serialization of products down to the saleable unit. Serialization enables the electronic and interoperable exchange of data between trading partners, as well as other communication tools like product verification and product tracing that should help prevent counterfeit medications from infiltrating the legitimate prescription drug supply chain. While full implementation of DSCSA has been delayed to ensure that patients do not experience access issues to medications, even when fully implemented, the law has some limitations that have and will continue to be exploited. Counterfeit prescription products continue to infiltrate the legitimate supply chain. Recent counterfeit events have highlighted numerous instances where valid unique product identifiers – Global Trade Item Numbers (GTINs), or serial numbers – were duplicated or reused by bad actors to insert dangerous products into the legitimate supply chain. Further collaborative efforts are required to prevent these dangerous products from entering the supply chain.

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